Received Dec 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
got covid a while back and it was mild/He got covid again and died from it; got covid a while back and it was mild/He got covid again and died from it; He got covid again and died from it; This is a spontaneous report received from a Physician. A 60-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), COVID-19 (death), outcome "fatal" and all described as "got covid a while back and it was mild/He got covid again and died from it"; DISEASE RECURRENCE (death), outcome "fatal", described as "He got covid again and died from it". The patient date of death was unknown. Reported cause of death: "got covid a while back and it was mild/He got covid again and died from it", "He got covid again and died from it". Clinical course: The reporter knew of a 60-year-old male that got covid a while back and it was mild. He got covid again and died from it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (COVID-19 and disease recurrence) with the suspect product BNT162B2 OMICRON (LP.8.1) cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.; Reported Cause(s) of Death: got covid a while back and it was mild/He got covid again and died from it; got covid a while back and it was mild/He got covid again and died from it; He got covid again and died from it